Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT04495504
Eligibility Criteria:
Inclusion Criteria:
* Patients who undergo scheduled cardiac surgery with sternotomy: aortic or mitral valve replacement, biological or mechanical, coronary bypass surgery
* Age under 85 years
* Patients who have given their consent according to the methods described in Title II of the book of the first Public Health Code
* Possession of Social Security insurance.
Exclusion Criteria:
* Emergency surgery
* Approach by thoracotomy
* Heart transplant
* Aortic dissection
* Redo surgery.
* Pregnant women
* Refusal of the protocol
* Protected minors or adults
* Pre-existing psychiatric pathology including known states of opioid addiction
* Long-term opioid medication
* Physical or intellectual inability to use a PCA
* Severe heart failure (ejection fraction less than 40% or PAH \> 50 mmHg)
* Preoperative cardiogenic shock
* Severe preoperative chronic or acute renal failure with a creatinine clearance of less than 30 mL / min according to Cockroft's formula
* Known hypersensitivity to local anesthetics or to any component of the catheter
* Known allergy or hypersensitivity to any of the study drugs or analgesia protocol (ropivacaine, paracetamol, opiates).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04495504
Study Brief:
Protocol Section:
NCT04495504